Spectros T-Stat

GUDID 10851136007008

Tissue saturation oximeter sensor, single-use

Primary Device ID	10851136007008
NIH Device Record Key	b4e14bd0-60d0-4408-b830-6dd41e0ab0ec
Commercial Distribution Status	In Commercial Distribution
Brand Name	Spectros T-Stat
Version Model Number	CTH-060-SUR 2.5cm
Company DUNS	929856680
Company Name	SPECTROS CORPORATION
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Phone	6508514040
Email	info@spectros.com

Device Issuing Agency	Device ID
GS1	00851136007001 [Primary]
GS1	10851136007008 [Package] Contains: 00851136007001 Package: Box [5 Units] In Commercial Distribution

MUD	Oximeter, Tissue Saturation

Steralize Prior To Use	false
Device Is Sterile	true

00851136007056	The T-Stat 303 Microvascular Tissue Oximeter provides a continuous, non-invasive, and localized
10851136007046	Oral sensor for use with the T-Stat Monitor to measure ischemia
10851136007039	Gastrointestinal sensor for use with the T-Stat monitor to measure ischemia in colorectal tissue
00851136007025	Endoscopic sensor for use with the T-Stat Monitor to measure ischemia
10851136007015	1 cm diameter surface sensor for use with the T-Stat Monitor to measure ischemia.
10851136007008	2.5 cm diameter surface probe for use with the T-Stat Monitor to measure ischemia.
00851136007063	The T-Stat 2.0 Microvascular Tissue Oximeter provides a continuous, non-invasive, and localized